CN105188797A - Transseptal cannula, tip, delivery system, and method - Google Patents

Abstract

A circulatory assist system for assisting the flow of blood through a patient circulatory system, comprising a cannula assembly (500) for directing blood from a heart of the patient, the cannula assembly (500) comprising a flexible cannula body (502) including a proximal end (504), a distal end (506), and a lumen (508) therebetween. A pump (594) for drawing blood from the heart into the cannula body (502) and dispensing the blood from the cannula body (502) and into the patient circulatory system, the pump (594) further including an inlet (596) and an outlet (598). An outflow cannula (600) configured to fluidicly communicate the outlet (598) and an artery of a patient. An adaptor device (602) configured to fluidicly communicate the inlet (596) and the cannula body (598), the adaptor device (602) including a proximal portion (604), a distal portion (606), and a body (608) therebetween.

Description

Spacer pipe, tip, delivery system and method in warp

The cross reference of related application

The application be on April 18th, 2011 submit to serial number be 13/088,620 (is U.S. Patent number 8 now, 394,010) the part continuation application of application, described serial number be 13/088,620 application be on October 23rd, 2008 submit to serial number be 12/256, application (the existing U.S. Patent number 8 of 911,343,029) divisional application, the disclosure of above-mentioned two parts of applications is incorporated to herein by reference.

Background technology

Human heart is the muscle being responsible for blood to be pumped across whole blood vessel network.Vein is the blood vessel carried towards heart by blood, and tremulous pulse carries blood away from heart.Human heart is made up of two atrial chamber and two ventricular chamber.Atrial chamber receives the blood from health and ventricular chamber, and described ventricular chamber comprises larger myocardial wall, from heart pump blood.In every separating the left side of heart and right side.The flowing of blood is as follows: blood enters right atrium from epicoele or postcava and flows in right ventricle.Blood is pumped to pulmonary via pulmonary artery to become the blood of oxygenate from right ventricle.Once blood is by oxygenate, then blood turns back to heart by entering left atrium via pulmonary vein, and enters in left ventricle.Finally, blood is pumped in aorta and blood vessel network from left ventricle.

For most population, the event relevant with blood flow occurs at any time.But for many people, heart can not provide enough pumpabilities.These heart failures may comprise congestive heart failure (being commonly called heart disease), and it is the state causing any structural or functional cardiac disease, and blood is full of whole health or is pumped across the ability of whole health by infringement heart.At present, there is no the method for known healing heart disease, and long-term treatment is limited to heart transplantation.Slightly heart transplantation is accepted more than the patient of 2000 owing to only having every year, and the patient more than 16600 or more is still on the waiting list of heart transplantation, continue demand for curing or at least existing the means of the quality of life of these patients improved on waiting list.

The so a kind of means shortening time difference when waiting for and transplanting are circulatory assit systems.Initial these systems researched and developed before more than ten years provide auxiliary by the mode of mechanical pump to heart.By this way, although there is afflicted cardiac tissue, blood still cycles through whole blood vessel network.From artconventionally, these circulatory assit systems comprise implantable pump or external pump, controller (inner or outside), and pump are connected to inflow and the effuser of blood vessel network.The dyspnea and fatigue symptom that are associated with severe heart failure are alleviated in the circulatory assit components of system as directed ground of FDA approval, and significantly improve the quality of living.

But the operation process be associated with circulatory assit system is very invasive.Program at least comprises thoracotomy, that is, the thoracic cavity opening between continuous print rib is with exposed inner organ.More typically operation on heart, is commonly called cardiac operation under direct vision, and wherein, breastbone is cut off and is separated with exposed inner organ.Once thoracic cavity is opened, surgeon must enter pleural space and puncture pericardium and myocardial wall.There is the recovery time of great risk and the prolongation be associated with the invasive of implant surgery in this.Therefore, the patient of some serious symptoms not health carry out performing the operation to accept circulatory assit system.

There is lasting demand in the improvement for this field.Such as, for while waiting for heart transplantation by obtain greatest benefit those patients for, provide larger utilizability to there is demand to the invasiveness by minimizing implant surgery to circulatory assit system.Specifically, the invasiveness minimizing program by least no longer needing to enter pleural space or puncture pericardium and myocardial wall is existed continue demand.In addition, for easy in heart external member or cardiac electrophysiology laboratory instead of the program performed in operating room there is demand, to increase availability for patient.

Summary of the invention

In one embodiment of the invention, circulatory assit system is provided.This system comprises cannula assembly, also comprises for the casing main body from patient's heart guide blood, and described casing main body has far-end and near-end and inner chamber therebetween.Cannula assembly also comprises the tip being connected to casing main body far-end, and described tip has opening.The invention provides a kind of pump, it enters in patient circulatory system for extract in blood to cannula assembly and distributed from cannula assembly by blood.The inner chamber of casing main body be also included in proximal end the first internal diameter and in the second internal diameter of far-end and conical section, wherein the first internal diameter is greater than the second internal diameter, and described conical section is restricted to the internal diameter minimizing part between the proximal and distal ends from the first internal diameter to the second internal diameter.Conical section is configured to prevent from sleeve pipe, occur blood cavitation.

In another exemplary embodiment of the present invention, provide circulatory assit system.This system comprises casing main body and pump, and described casing main body has far-end and near-end and inner chamber therebetween, and described pump enters in patient circulatory system for extracting to distribute from cannula assembly in blood to cannula assembly and by blood.This system also comprises tip, and it is communicated with described cavity fluid at the far-end of casing main body, and is configured to inner chamber to be communicated with the chamber of heart.Described tip comprises distal portions, and described distal portions has first end and the second end, and described first end and the second end have the first diameter and Second bobbin diameter respectively, and the second end is more farther than first end, and Second bobbin diameter is greater than the first diameter.Tip is configured to prevent from entering tip and blood pressure through sleeve pipe reduces.

In another exemplary embodiment of the present invention, provide circulatory assit system.This system comprises cannula assembly and pump, and described cannula assembly has far-end and near-end and inner chamber therebetween, and described pump enters in patient circulatory system for extracting to distribute from cannula assembly in blood to cannula assembly and by blood.This system also comprises delivery sheath (deliverysheath), and it passes through patient circulatory system for delivery cannula molectron.Delivery sheath is configured to receive cannula assembly and moves relative to it so that the contiguous chambers of the heart disposes sleeve pipe, and described delivery sheath also comprises far-end, near-end and main body therebetween.Described main body also comprises tension element that the longitudinal direction that is embedded into wherein arranges and described tension element is configured to prevent bulk deformation when cannula assembly moves relative to delivery sheath.

In another exemplary embodiment of the present invention, the delivery system provided is for the heart of the cannulated delivery to patient that will comprise anchoring piece.Anchoring piece has contraction and deployed condition, and delivery system comprises delivery sheath, and sheath is configured to receive cannula assembly and move relative to it so that under anchoring piece is deployed to deployed condition.Delivery system also comprises loading attachment, described loading attachment be configured to receive be in anchoring piece under contraction state and auxiliary by cannulated delivery in delivery sheath, under wherein anchoring piece is in contraction state.This loading attachment also comprises near-end, far-end and inner chamber therebetween, and near-end has the first internal diameter and far-end has the second internal diameter, and the first diameter is greater than Second bobbin diameter.This loading attachment the first internal diameter be also included in inner chamber changes to the stepped part of the second internal diameter, and the conical section in stepped portion office, and described conical section is restricted to the part that the internal diameter between the first internal diameter and the second internal diameter reduces.Conical section is configured to prevent from when sheath receives cannula assembly damaging anchoring piece.

In another example embodiment of the present invention, provide the circulatory assit system flowing through patient circulatory system for assist blood.This system comprises for the cannula assembly from patient's heart guide blood, and described cannula assembly comprises the casing main body of flexibility (flexible), and described casing main body comprises near-end and far-end and inner chamber therebetween.This system also comprises pump, and it enters in patient circulatory system for extract in blood to cannula assembly and distributed from cannula assembly by blood, and described pump also includes an inlet and an outlet.This system is also included in the adaptor device between entrance and cannula assembly, is communicated with by entrance thus with cannula assembly fluid.This system also comprises and will export the outflow sleeve pipe be communicated with the arterial fluid of patient.Entrance is set to towards (lateral) direction, roughly outside relative to patient.

In another exemplary embodiment of the present invention, provide method circulatory assit Account Dept be deployed in the blood circulation of patient.Aid system comprises cannula assembly and pump, and assist blood flows through blood circulation.The method comprises and is directed in the blood circulation of patient by cannula assembly, the far-end of wherein said cannula assembly is communicated with heart chamber fluid, and main body advances to superior vena cava and subclavian vein from heart chamber, left by the point of cannula assembly at subclavian vein.The method also comprises and being communicated with tremulous pulse and the outflow collar fluid between them by delivery side of pump, and cannula assembly be communicated with the entrance of pump and the boot adapter fluid between them, the wherein said entrance of adaptor is set to towards the roughly lateral direction relative to patient.

Accompanying drawing explanation

Figure 1A to 1E be with shown in section enter in human heart every the schematic diagram of illustrative methods.

Fig. 2 A is the perspective view of anchoring director element.

Fig. 2 B is the enlarged cross sectional view intercepted along the line 2B-2B of the end turn of anchoring director element.

Fig. 2 C to 2E is the perspective view of the alternate embodiment of the anchorage characteristics of anchoring director element.

Fig. 3 is the longitudinal profile of the method be loaded into by anchor in percutaneous warp in the wheel hub of sheath.

Fig. 4 A to 4D is the stable schematic diagram extending through the method for the fiber of the anchoring director element at upper cut position.

Fig. 5 is with the schematic diagram by being implanted to the illustrative methods in human heart in warp every cannula assembly shown in section.

Fig. 6 be with shown in part section have through in every the side view of the delivery device of cannula assembly.

Fig. 6 A is the cross section view being similar to the substituting conduit axle shown in figure.

Fig. 7 A be through in every the perspective view of an embodiment at the tip of cannula assembly.

Fig. 7 B is the cross section through middle spacer pipe embodiment, and wherein the anchor tip of left side and right side anchoring piece is aligned with each other.

Fig. 8 A is the perspective view of an embodiment of the anchoring piece used together with tip shown in Fig. 7 A.

Fig. 8 B is the front view of another embodiment of anchoring piece of cross-section.

Fig. 8 C is the side view of anchoring piece shown in Fig. 8 B.

Fig. 8 D illustrates with deployed condition and is arranged on the front view of the first and second anchoring pieces in the cannula tip shown in Fig. 7 A.

Fig. 8 E be along illustrating with deployed condition of intercepting of the line 8E-8E of Fig. 8 D but not shown in every the side view of the first and second anchoring pieces.

Fig. 9 A is with the decomposition diagram of the far-end loading attachment shown in part section.

Fig. 9 B be with the assembling of the far-end loading attachment shown in Fig. 9 A shown in part section after profile.

Figure 10 A to 10D show with shown in part section by described far-end charging appliance be loaded onto in delivery device through in every cannula assembly.

Figure 11 A is the perspective view of the alternate embodiment of delivery apparatus.

Figure 11 B be illustrate through in the longitudinal cross section of a delivery apparatus part shown in Figure 11 A of loading every cannula assembly.

Figure 12 A to 12D is with the side view every the illustrative methods of the anchoring piece of cannula assembly in the expansion warp shown in part section.

Figure 13 is with the schematic diagram being placed on the exemplary cycle aid system in human heart shown in section.

Figure 14 is the side view every another embodiment at cannula assembly tip in the warp according to another embodiment.

Figure 15 be through in every the decomposition diagram of the alternate embodiment of cannula assembly.

Figure 16 A be through in every the decomposition diagram of the another alternate embodiment of cannula assembly.

Figure 16 B is every the longitudinal profile of cannula assembly along line 16B-16B in the warp shown in Figure 16 A.

Figure 17 is with the side view of the alternate embodiment of the delivery apparatus shown in part section.

Figure 18 A is the side view of the distal portions of another embodiment of the delivery apparatus with truncate sheath.

Figure 18 B is that truncate sheath is retracted and the side view of distal portions of Figure 18 A illustrated embodiment before the expansion of the first anchoring piece.

Figure 19 A is the perspective view of an embodiment of cannula assembly.

Figure 19 B is the longitudinal sectional view of the cannula assembly shown in Figure 19 A.

Figure 20 is the detailed cross sectional view of the cannula assembly shown in Figure 19 A.

Figure 21 A is the perspective view of an embodiment of delivery sheath.

Figure 21 B is the detailed perspective view of the delivery sheath shown in Figure 21 A.

Figure 21 C is the detailed cross sectional view of the wheel hub of the delivery sheath shown in Figure 21 A..

Figure 22 A to 22D illustrates sectional view cannula assembly being loaded into involved step in loading attachment.

Figure 22 E is the detailed section view that loading attachment is shown, wherein cannula assembly is directed in the wheel hub as described in Figure 21 C as shown in Figure 22 D.

Figure 23 A be with shown in section enter in human heart every the schematic diagram of illustrative methods.

Figure 23 B be with shown in section enter in human heart every the schematic diagram of illustrative methods, it illustrates the alternative arrangements of boot adapter and blood pump.

Figure 23 C is the detailed side view of the boot adapter shown in Figure 23 B.

Figure 23 D is the side view that the boot adapter shown in Figure 23 B connects with casing main body.

Specific embodiments

Implant circulatory assit system to start every hybridization procedures in percutaneous warp.Figure 1A-1E shows a part for the program according to an embodiment, and described embodiment relates to places anchoring director element every 102 in the atrium of heart 104.Described method starts from surgeon and cuts out in patient 108 body roughly near the major incisions position 106 of superficial vein.The superficial vein being suitable for major incisions position 106 can comprise and is positioned on the left of patient or the peripheral vein on right side, such as left side or right lateral thigh vein 109,110, or by other peripheral vein well known by persons skilled in the art.Usually preferably, major incisions position 106 is lower than secondary cutting part 111, described secondary cutting part 111 is roughly near suitable superficial vein, it comprises peripheral vein, such as right subclavian vein 112, jugular vein 113, the intersection between right subclavian vein 112 and jugular vein 113, or by other suitable peripheral vein well known by persons skilled in the art.Also the similar vein or position that are positioned at left side of body can be used.

Due to heart and in every relative to postcava and superior vena caval angle, use low cutting part be more suitable for entering in left atrium and atrium every.But some programs (such as implanting circulatory assit system) need to be in higher cutting part.Consequently, as will be described in detail, surgeon can find its be conducive to first entering in every and then be transitioned into secondary cutting part.

Surgeon starts the program shown in Figure 1A by following step, by the snaring device 114 of standard from secondary cutting part 111, along superior vena cava 116, right atrium 117, postcava 118, guide and arrive right lateral thigh vein 110, and by major incisions position 106.Standard ring covering device 114 can be included in the main body 120 extended between main and secondary cutting part 106,111, and the snare ring 121 on the far-end being positioned at main body 120.Alternatively, although do not illustrate, snare ring 121 can remain in right lateral thigh vein 110, and does not extend through major incisions position 106.

Surgeon can enter subsequently and stride across in atrium every 102.For percutaneous through in every the appropriate device of intersecting can be have percutaneous through in every sheath 124 through in send delivery system 122 every what enter, described sheath 124 have far-end 125, near-end 126, the inner chamber (not shown) extended betwixt and percutaneous through on the near-end 126 of sheath 124, be positioned at the wheel hub 128 of nearside.Far-end 125 every sheath 124 in Guided Percutaneous passes through snare ring 121, enters in major incisions position 106, upwards arrives postcava 118, and enter in right atrium 117.

Once enter right atrium 117 every sheath 124 in percutaneous warp, being loaded into returning the wheel hub 128 being positioned at nearside together with the seal wire 130 extending through it every pin (not shown) in wearing, by the inner chamber every sheath 124 in percutaneous warp, and entering right atrium 117.Wear every 102 in pin (not shown) puncture atrium, and allow seal wire 130 to enter left atrium 132.Percutaneous through in every the far-end 125 of sheath 124 cross wear in advance every pin, puncture in 102 in atrium, and enter in left atrium 132.Advance by using occluder 134 to enable every this of sheath 124 in percutaneous warp; But the method should not be regarded as being limited to this.

In percutaneous warp after the far-end 125 of sheath 124 is in left atrium 132, retract (see Figure 1B) completely every pin (not shown) and seal wire 130 in wearing, only stay in percutaneous warp and be positioned at left atrium 132 every sheath 124.Be ready to now receive according to one of this paper embodiment with at the anchoring director element hereafter explained in detail every the delivery system 122 entered in warp.

Typically, anchoring director element comprises the main part with near-end and far-end, and wherein said far-end comprises anchorage part.Can supplementary features be comprised and hereafter provide in detail.

As shown in Figure 2A and 2B, the main part of anchoring director element can be configured to line 138, and it has the internal core 140 that can be encapsulated in coil 142 and/or polymerization sheath (not shown).Heart yearn 140 forms (such as Nitinol, i.e. NiTi) by elastic material and exceedes the length of line 138, and diameter range will from about 0.127mm to about 0.254mm.Heart yearn 140 can be taper or stair-stepping, and this depends on required level of flexibility (namely larger tapering will increase flexibility).Coil 142 can be made up of the tight pitch coil of metal material (such as rustless steel or platinum), and can to comprise effective diameter range be from about 0.0254mm to the circle of about 0.127mm or rectangular cross section.Typically, the scope of the whole length of line 138 can from about 30cm to about 300cm, and this will depend on the distance between heart and cutting part.As by hereafter discuss, this structure provide help surgeon handle anchoring director element by percutaneous through in every the motility of sheath.

Coil 142 can be connected by terminating radius 145 at near-end 144 place according to Fig. 2 B with heart yearn 140, and described end radius is by laser beam welding, solder technology or other known method carrys out connecting coil 142 and heart yearn 140 is formed.After coil 142 is connected with heart yearn 140, line 138 usable polymers material (not shown) (such as polyethylene or fluorinated polymer) coatings, this will improve the motion of line 138 relative to the surgical device be coaxially directed on line 138.

Again get back to Fig. 2 A, the far-end 146 of line 138 is illustrated as straight part, and it can be the extension of heart yearn material.Far-end 146 provides rigid region, and it can be pre-formed as required to provide support to the coaxial device of loading and the transition portion between main part and anchorage part, and this will be described below.The length range of far-end 146 is as required or expect, from about 1cm to about 10cm.

Anchoring director element comprises the anchorage part be positioned on main part far-end.Although anchorage part can comprise any amount of configuration, specifically describe three kinds of configurations herein: double bend 160 (Fig. 2 A), multiple pillar 150 (Fig. 2 C and 2D), and ring 162 (Fig. 2 E).

The double bend 160 of Fig. 2 A can comprise the first and second sweeps 164,166 being positioned over line 138 far-end 146 place.First and second sweeps 164,166 can direction relatively (i.e. roughly separately 180 ° of placement), once double bend relatively in every (not shown) placement, described first and second sweeps will optimize load-bearing benefit.End sections 168 can extend from the position proximad of double bend 160.The far-end 146 of line 138 is fixed to the near-end 170 of double bend 160 by standard cohesive process (such as welding or gummed).If necessary, thin polymer sleeve (not shown) can be comprised end sections 168 is fixed to near-end 170.

The double bend 160 of Fig. 2 A can online 138 far-end 146 place formed by the secondary forming process of heart yearn material, heart yearn material is the extension of main part.Alternatively, double bend 160 can be formed separately from similar material, and then the near-end 170 of double bend 160 is attached to the far-end 146 of line 138 by welding or gummed.

In fig. 2 c, anchorage part is illustrated as multiple pillar 150.Typically, described multiple pillar 150 extends substantially transversely to central axis and extends, and described central axis is represented by main part (be illustrated as fiber 148, this will be discussed below).Although illustrate four pillars 150, this quantity is not limited in this.On the contrary, it is contemplated that following embodiment, wherein need two pillars 150 for concrete surgical demand or preference or reach six or eight pillars 150.In order to softening wire rod raw material, coil (not shown) can add the distal portions of each pillar 150 to.Alternatively, pillar 150 usable polymers dip-coating.Each in described multiple pillar 150 can from the shape needed for the smooth sheet stock formation of elastic material (such as NiTi or MP35N).Although parallel position does not illustrate in the drawings, elastic material allow each in described multiple pillar 150 folded and/or remain on be parallel to central axis position under.Once release, appliance for releasing single is got back to deployed condition (Fig. 2 C) by described multiple pillar 150, and wherein said deployed condition is transverse to central axis.Alternatively, each in described multiple pillar 150 forms from the wire rod of material requested and forms required form.The thickness range of each in described multiple pillar 150 can from being approximately 0.13mm rice to about 0.25mm, and length range can from about 0.025mm to about 0.51mm.Upon formation, each the experienced secondary operations in multiple pillar 150, such as electrobrightening, the Roughen Edges produced during to remove and to form desired curvature.

As shown in Fig. 2 C further, multiple pillar 150 is attached to fiber 148.Fiber 148 can from the standard suture material (such as polypropylene (politef be such as etched; EPTFE)) make.Because fiber 148 lacks the rigidity level being suitable as seal wire, therefore anchoring Magnet 152 is included to be provided for device enhancing structure be attached on fiber 148, and this will discuss below in detail.The external diameter of anchoring Magnet 152 is substantially equal to the diameter (namely under normal circumstances about 0.127mm to about 6.35mm) of conventional guidewire and has total length, make when multiple pillar 150 (or other anchorage part) to reside in left atrium 132 (Figure 1A) and in atrium in when 102 (Figure 1A), the near-end 154 of anchoring Magnet 152 will reside in right atrium 117 (Figure 1A).Typically, the anchoring Magnet of length range from about 1mm to about 5mm be enough to adapt to various every thickness.Fiber 148 extends through the internal diameter (not shown) of anchoring Magnet 152, and passes through the middle body 155 of multiple pillar 150.Fiber 148 is fixed on far-end 156 place by welding or other means.

Fig. 2 D illustrates alternate embodiment, and wherein flexible wires 157 (being such as made up of NiTi) is soldered to wheel hub 158, and described wheel hub 158 is such as made up of to locate radiopaque material.Flexible wires 157 or can comprise TEFLON or be suitable for reducing other polymeric layer of coefficient of friction by solution impregnation.The near-end (not shown) of flexible wires 157 structurally can be similar to coil 142 and the heart yearn 140 of Fig. 2 B.The described multiple pillars 150 extending substantially transversely to central longitudinal axis extension are soldered on wheel hub 158.Although do not specifically illustrate, each the comprised spring coil in described multiple pillar 150 and the end radius part be positioned on each far-end, structure is similar to the main body of Fig. 2 B.In addition, each the comprised curvature in described multiple pillar 150, the outer end making described multiple pillar 150 each than the inner end be positioned near wheel hub closer to wheel hub.

Fig. 2 E illustrates the 3rd embodiment of anchorage part, namely has the ring 162 of distal portions 172 and near-end (not shown).Ring 162 is formed by heat treatment process.The end sections 172 of ring 162 can be the molectron of core and coil, and this molectron is similar to the line of Fig. 2 A to provide the rigidity of increase to end sections 172 on structure and material, and this contributes to surgeon's commanding apparatus.In this article, the length range of end sections 172 can from about 1cm to about 5cm, and this depends on the required form of ring 162.That is, if need " straight " shape, then the length of about 1cm can be suitable; But " j " or other shape may need at least 5cm.

The embodiment no matter adopted, anchorage part also can comprise the part be made up of platinum or platinum-iridium rustless steel, to change the ray impermeability of anchorage part.Radiopaque material (such as platinum-iridium, rustless steel, tungsten or tantalum) allows device to pass through non-invasive device (in such as X-ray, real-time fluoroscopic or heart ultrasonic cardiograph) remote visible in vivo.

By by the detailed description of some details to exemplary anchoring director element, the method inserting anchoring director element can continue with reference to Figure 1B-1D.Although these accompanying drawings illustrate that anchoring director element is specially the fiber 148 with multiple pillar 150, should be understood that other embodiment, such as above is applicable for any embodiment described in main part and/or anchorage part.

Figure 1B illustrates and is loaded into multiple pillars 150 in wheel hub 128 via loading pipe 174 back side.Loading pipe 174 (more detailed in Fig. 2) will cause multiple pillar 150 can deflect into from deployed condition (shown in broken lines) position (as discussed previously) being arranged essentially parallel to central axis.Load pipe 174 and also can be used as the machinery opening haemostatic valve (showing for O shape ring 175) in wheel hub 128.In operation, multiple pillar 150 is positioned at the proximal end of loading pipe 174.Load in pipe 174 by being advanced to by multiple pillar 150, keep loading pipe 174 simultaneously and fix, multiple pillar 150 deflection makes described anchorage part deflect and enters to load pipe 174.If necessary, due to the non-rigid characteristic of fiber 148, pillar 150 is advanced and to complete by ejector sleeve 176.Therefore, the far-end 176 of ejector sleeve contacts with anchoring Magnet 152, thus guides multiple pillar 150 to enter into load pipe 174 and percutaneous through in sheath 124 (Figure 1B), and finally enters in left atrium 132 (Figure 1B), as described below.Structurally, ejector sleeve can be the cylindrical structural of hollow, and this structure allows fiber 148 through wherein extending.In some cases, ejector sleeve 176 can be configured to the solid cylindrical configuration be polymerized or metal material is formed, as shown in fig. 1b.

In operation, and as by by checking Figure 1B and 1C understand, described multiple pillar 150 travels across the inner chamber every sheath 124 in percutaneous warp by ejector sleeve 176, until the far-end 125 of multiple pillar 150 every sheath 124 from percutaneous warp occurs, thus enters left atrium 132.Utilize ejector sleeve 176 make multiple pillar 150 continue to advance extend to percutaneous through in outside sheath 124, this cause in multiple pillar 150 each be deployed into position (as previously mentioned) transverse to central axis from the position being parallel to central axis.

As is shown in fig. 1 c, once multiple pillar 150 is deployed in left atrium 132, then surgeon can retract in percutaneous warp from major incisions position 106 every sheath 124 and ejector sleeve 176, and multiple pillar 150 is kept original position in left atrium 132, and this is shown in Fig. 1 D.The slight retraction of the near-end (not shown) of fiber 148 or pull pillar 150 multiple in left atrium 132 is pulled into in the atrium in left atrium 132 in contact every 102, and fiber 148 extends from major incisions position 106 and by snare ring 121.Snare ring 121 can operate into subsequently and makes fiber 148 from major incisions position 106 transition or move to secondary cutting part 111.

Fig. 1 E illustrates the snare ring 121 when surgeon starts to regain snare equipment 114 and makes fiber 148 to be transitioned into secondary cutting part 111 from major incisions position 106.Described multiple pillar 150 is fixed in the atrium in left atrium 132 every 102 and every 102 removals stoping anchoring director element in atrium.By retraction snaring device 114, form the prolapsed portion 190 of fiber 148, and near-end 180 extends beyond major incisions position 106.In certain embodiments, described snare ring 121 can lock near the near-end 180 of fiber 148.

Fig. 1 E illustrates the snaring device 114 after continuing to retract, and it causes the ring portion (shown in broken lines) of snare ring 121 (shown in broken lines) and fiber 148 to stretch out from secondary cutting part 111.The near-end 180 of fiber 148 extends beyond major incisions position 106.The ring portion of fiber 148 extends to the first side 191a of anchorage part by having from described ring portion and extends to the second side 191b of fiber near-end 180 from ring portion.Then surgeon slightly can pull the first side 191a and/or the second side 191b of fiber 148 ring portion, to determine which extends to anchorage part.That is, when the second side 191b when pulled, vision movement can be detected at near-end 180 place; Otherwise, if the first side 191a is pulled, then can't detect movement.By this way, too large power can not be applied to the first side 191a by surgeon unintentionally, thus anchorage part is pulled through in atrium every 102.

Extended from secondary cutting part by the near-end of anchoring director element, can guarantee in percutaneous warp subsequently every program.But as mentioned earlier, fiber 148 can not provide enough rigidity level to be coaxially positioned on fiber 148 to support surgical device.Therefore, may it may be necessary and strengthen the rigidity that structure (such as crossing line molectron) increases fiber 148, as described below.

Fig. 4 A illustrated line molectron 192, to increase the intensity of anchoring director element.Cross line molectron 192 and comprise the main body 194 with the Magnet 196 being positioned at far-end.Main body 194 will be placed on fiber 148, to provide the rigidity of increase.Main body 194 can be made up of polymer (such as polyimides or polyamide) or metal (such as rustless steel or NiTi) material.When a polymer material, the outer surface of polymeric material can be coated with the material reducing skin-friction coefficient, such as lubricant coating further.When using metal material, main body 194 can be by circular or flat thread continuous coil, or can be the hypotube (hypotube) with the spiral type cut pointed to towards main body 194 far-end.

Magnet 196 can operate into, at multiple pillar 150 place, the main body 194 crossing line molectron 192 is attached to anchoring Magnet 152.Therefore, Magnet 196 is made up of the previously described material being similar to anchoring Magnet 152, but has contrary magnetic polarity, so that anchoring Magnet 152 is coupled to Magnet 196.Magnet 196 is secured to the far-end of main body 194 by welding or gummed or other suitable method.

What illustrate further in Figure 4 A is fiber acquisition equipment 198, and it comprises line 199, is positioned at the wheel hub 200 of nearside, and with cross the ring 202 being positioned at distally of line molectron 192 conbined usage.In operation, ring 202 can be used as pin, and it is for passing main body 194 by fiber 148, but this method will hereafter describe in more detail.Line 199 and ring 202 can comprise wire rod, and it is similar to the material of standard ring covering device.Socket 200 can be the structure of any amount, and it provides handle to fiber acquisition equipment 198, and guarantees that the near-end of fiber acquisition equipment 198 does not enter main body 194.Line 199 and ring 202 can be loaded in main body 194 in advance, make ring 202 shown as extend beyond Magnet 196.

In operation, and according to Fig. 4 A and Fig. 4 B, the near-end 180 of fiber 148 passes the ring 202 of fiber acquisition equipment 198 while extending from secondary cutting part 182.The wheel hub 200 of fiber acquisition equipment 198 departs from main body 194 subsequently, thus pulls ring 202, together with the inner chamber of fiber 148 by main body 194, as shown in Figure 4 B.Fiber acquisition equipment 198 then complete removing from main body 194 makes fiber 148 extend from main body 194 proximad.

Proceed to now Fig. 4 C, then main body 194 can advance at fiber 148, simultaneously surgeon remain in fiber 148 and left atrium 132 multiple pillars 150 on tension force.When main body 194 and Magnet 196 close in atrium every 102 time, magnetic is coupled to form continuous print platform by Magnet 196 and anchoring Magnet 152, and it can make the device added stably advance to and across line molectron 192.In other embodiments, anchoring Magnet 152 also can comprise importing feature (not shown), and it is as the suitable aligning guaranteeing anchoring Magnet 152 and Magnet 196 and the end difference be coupled.

In order to complete line molectron 192 excessively as shown in FIG. 4 C, unidirectional fibre folder 204 is directed on the near-end 180 of fiber 148, with the main body 194 preventing the near-end 180 of fiber 148 from reentering line molectron 192, and guarantee that the tension force of between anchoring Magnet 152 and Magnet 196 (namely along fiber 148) keeps.Once fiber clamp 204 contacts main body 194, then fiber clamp 204 clamping closure, and pruned from the near-end 180 of the fiber 148 of fiber clamp 204 proximad extension.

Then, as shown in fig.4d, the main body 194 with the fiber clamp 204 be held in place is ready to receive any suitable surgical apparatus coaxially.Such as, through in spacer tube apparatus to be coaxially positioned in fiber clamp 204 and secondary cutting part 182 can be entered in company with main body 194, along right subclavian vein 112, superior vena cava 116, and entering in the right atrium 117 of heart 104.

Although guide the method for anchoring director element to use fiber to be described by some details and to illustrate, it is easily understood that also can line be used.Similarly, although the method has used multiple pillar to be described by some details and to be illustrated, it is easily understood that alternatively dispose ring, double bend or other anchorage part.

Although do not specifically illustrate, can surgical procedures be continued from major incisions position and anchoring director element is not transitioned into secondary cutting part from major incisions position for surgeon.By this way, snaring device will not be used.

In addition, for surgeon can also directly from single incision site enter in atrium every, and without the need to creating main and secondary cutting part and without the need to using snaring device.By this way, single cutting part is located substantially near secondary cutting part, as mentioned above.Standard guide wire, occluder and steerable sheath can be directed in single cutting part by surgeon.By using the control wire can handling sheath, molectron can be guided through right subclavian vein by surgeon, superior vena cava, and enters right atrium.Once arrival right atrium, during surgeon guides standard guide wire to cross every and enter left atrium.

Finally, in some cases, surgeon may wish to replace anchoring director element with standard guide wire before performing the operation, instead of uses enhancing structure, such as crosses line molectron.Therefore in this respect, surgeon will insert sheath by secondary cutting part, arrive right atrium downwards, in crossing every, and to enter in left atrium.While pulling the main part of anchoring director element, keep sheath to fix, surgeon can make anchorage part be retracted in the inner chamber of sheath.Continue to pull main part that anchoring director element will be made to retract from secondary cutting part, and sheath remains in left atrium.Then surgeon can to insert standard guide wire by sheath and arrive left atrium.After confirmation seal wire is in left atrium, surgeon can make sheath retract from secondary cutting part.

Close in every afterwards, for implant be suitable for circulatory assit system through in every cannula assembly program can according to shown in Fig. 5 method continue, Fig. 5 illustrates that anchoring director element is ring 162 and line 138.But, should be understood that, the embodiment of any aforesaid anchoring director element can be used.

As shown in Figure 5, be coaxially loaded on line 138 by delivery apparatus 208 every cannula assembly (not shown) in warp, enter secondary cutting part 111, through right subclavian vein 112, superior vena cava 116, and enter in right atrium 117.Delivery apparatus 208 can operate into along line 138 send be included in delivery sheath 210 through in arrive in atrium every 102 every cannula assembly (being described below in detail).

As shown in Figure 5 and by being shown in further detail in Fig. 6, the wheel hub 212 that delivery apparatus 208 comprises delivery sheath 210 and connects with the near-end of delivery sheath 210.Although it is illustrated as single-wall structure in figure 6, delivery sheath 210 is preferably configured as three thin layer walls.Skin can by polyurethane, nylon 11, nylon 12 or PEBAX, form; Internal layer can be the lining be made up of ePTFE, urethanes or nylon and hydrogel coating; Intermediate layer can be made up of braided material, such as stainless steel silk, Nitinol, or polyether-ether-ketone (PEEK) fiber, to provide structural stability to delivery sheath.Internal layer or interior lining can be extruded and be placed in axle, and wherein intermediate layer and skin are formed respectively or be placed on the contrary on internal layer.Then polyurethane to be placed in whole molectron and thermal contraction winding pipe so that stability.Alternatively, delivery sheath 210 is by reflux course lamination.In some cases, the super-elasticity coil 214 around delivery sheath 210 can be comprised, to increase the rigidity of delivery sheath 210.Alternatively, the metal braid (not shown) around delivery sheath 210 can be comprised.Polymeric layer 215 around super-elasticity coil 214, can reduce friction when moving in blood vessel network with convenient delivery sheath 210.Also lubriation material is comprised by allowing, such as HYDROMED or polyamide, to reduce friction in box lunch warp when cannula assembly is mobile in delivery apparatus 208 for delivery apparatus 208.

Wheel hub 212 is attached to the near-end of delivery sheath 210 by gummed, welding or other means.Wheel hub 212 generally includes the device for being attached to Y-connection 216.Y-connection 216 can operate into for receiving other surgical operating instrument by main port 218, such as foley's tube (seeing below), prevents from refluxing at surgery body fluid simultaneously.Lateral port 220 allows the limited fluid path by valve 222 (Fig. 5).Although not shown, socket 212 can be attached to any suitable hemostasis seal, to prevent body fluid from refluxing, and should not be limited to shown Y-connection.

Proceed to Fig. 6 now, its be for delivery apparatus 208 and through in every the more detail of cannula assembly 224, delivery apparatus 208 will through in every cannula assembly 224 send stride across in atrium every in case subsequently with circulatory assit Dynamic System.Comprise flexible sleeve main body 226 every cannula assembly 224 in warp, be connected to the tip 228 of the distal part of flexible sleeve main body 226, and be connected to first and second anchoring pieces 230,232 of most advanced and sophisticated 228.Each anchoring piece 230,232 comprises multiple pillar 234.As shown in the figure, the second anchoring piece 232 comprises the porous polymer structure 236 on pillar 234 further.Once suitably implant every cannula assembly 224 in whole warp, then will create the shunting of oxygenated blood, it flow to implanted pump from heart left atrium, and arrives blood vessel network at a distance.

Structure through in cannula assembly 224 process, the wall of flexible sleeve main body 226 is preferably designed by the thermoplasticity of the soft of biological ruggedness or thermoset elastomer materials.Specifically, it can comprise the aliphatic extruded, polycarbonate-based polyurethane; Aliphatic poly ether-based polyurethane; Aromatic polyether type polyurethane; Aromatic copolycarbonate system polyurethane; Silicone modified polyurethane; Or silicone.Anti-microbial agents can be embedded in flexible sleeve material of main part before forming process, effectively to reduce or eliminate biomembranous existence and to reduce potential infection.Alternatively, this anti-microbial agents can be applied on the surface of flexible sleeve main body 226 after molding process completes.In addition, although this does not specifically illustrate, flexible sleeve main body 226 can be configured to multilamellar.

Once flexible boot body 226 is suitably formed, it is cut into required length.Nearside and distal part 227,229 can form about twice of the remainder thickness of described flexible sleeve main body 226, and it can contribute to the pump and most advanced and sophisticated 228 flexible sleeve main body 226 being connected to respectively circulatory aid.Also can use other thickness being suitable for portions of proximal and distal part, and be limited to the internal diameter of delivery sheath 210.The thicker portions of proximal 227 of flexible sleeve main body 226 also can contribute to the space between closed described flexible sleeve main body 226 and delivery sheath 210, make when the foley's tube back side is loaded, foley's tube can not move to the space between delivery sheath 210 and flexible sleeve main body 226.Alternatively, portions of proximal 227 and distal part 229 can enlarging flexible sleeve main body 226 to be connected to respectively the pump and most advanced and sophisticated 228 of circulatory aid.

In certain embodiments, lubricant coating or layer can be comprised in the outside of flexible sleeve main body 226.Such lubricating layer will contribute to the movement of flexible sleeve main body 226 relative to delivery apparatus 208.The suitable material being suitable for layer can comprise ePTFE, PEP (FEP), ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), high density polyethylene (HDPE) (HDPE), PEBAX or polyamide material, be coated with the lubricant coating being similar to HYDROMED.

Referring again to Fig. 6, its illustrate when implant through in every cannula assembly 224 time the foley's tube 238 that is combined with delivery apparatus 208.The foley's tube 238 being suitable for using in the method, by comprising by the compatible sacculus 240 formed to non-conforming shaped material, comprises nylon 11, nylon 12, polyurethane, PA polybutyleneterephthalate (PBT), PEBAX, or polyethylene terephthalate (PET).This sacculus 240 is connected to the distal part of conduit axle 242, and conduit axle 242 can be made up of the material identical or different with sacculus 240.Sacculus 240 arrives the connection of conduit axle 242 by hot gluing, binding agent, solvent or covalent bonding.The portions of proximal of conduit axle 242 can comprise Y-connection valve 244, and wherein strain relief 246 is for transition between rigidity Y-connection valve 244 to flexible catheter shaft 242.Y-connection valve 244 can comprise main port 248 and lateral port 250, and wherein lateral port 250 can comprise stop cock (not shown), expands or reduce for sacculus 240.The far-end of conduit axle 242 can comprise indicia band 251, for providing sacculus 240 position in vivo and aligning.

In certain embodiments, all alternatives cross-section as shown in FIG, balloon catheter shaft 242a also can comprise at least one inner chamber 252, and described inner chamber comprises at least one control wire 253 for handling this sacculus 240.At least one control wire 253 will extend through inner chamber 252 and arrives the operating mechanism (not shown) being attached to Y-connection valve 244 from the remote point (not shown) in sacculus 240 (Fig. 6).Operating mechanism will comprise sliding part (not shown), and it can operate into and pull control wire, thus cause the far-end of sacculus 240 can lateral deflection.Once release, sacculus 240 will turn back to non-inflection point.Foley's tube 238 also will comprise inflation lumen 255, for transmitting the fluid expanding to sacculus 240 or reduce.

Forward now Fig. 7 A to, illustrate in greater detail and describe through in every the tip 228 of cannula assembly.Typically, most advanced and sophisticated 228 comprise portions of proximal 228a, mid portion 228b, and distal part 228c.Opening 254 extends through nearside, centre and distal part 228a-c, and provides the fluid between left atrium and flexible sleeve main body 226 (Fig. 6) to be communicated with.In a preferred embodiment, nearside, centre and distal part 228a-c are made up of titanium alloy (such as TiAI6VAEL1) standard turning, line electrode electric discharge processing (EDM) or other processing technique.In this respect, and as clearly illustrated in the sectional view of Fig. 7 B, most advanced and sophisticated 228 is integrally-built rigidity tips 228.As in fig. 7 further shown in, the distal part 228c of most advanced and sophisticated 228 can comprise the shape by reducing fluid resistance, but most advanced and sophisticated 228 should not be considered as limiting in the shape specifically illustrated.Similarly, the means that portions of proximal 228a can need according to fluid and described flexible sleeve main body is connected to most advanced and sophisticated 228 are shaped.

Continue with reference to Fig. 7 A and 7B, most advanced and sophisticated 228 can comprise one or more ring 256 further, provide described ring for several reason.These rings 256 can engage anchoring piece 230, and the mode of 232 works (with reference to Fig. 7 B).By this way, ring 256 can combine with fixture 258 (Fig. 7 B) and work anchoring piece 230, and 232 are fixed on most advanced and sophisticated 228.In addition, these rings can be used for settling anchoring piece 230,232, and to a certain extent can by keying to keep the direction of described anchoring piece.Suitable fixture 258 can comprise as shown in the figure or other configuration, such as, but not limited to, swaged forging or compression joint type fixture.Fixture 258 is attached to most advanced and sophisticated 228 alternatively by binding agent, welding or tie up.Most advanced and sophisticated 228 also can be included in the one or more barbs 260 on most advanced and sophisticated 228 near-end 228a.Barb 260 provides resistance to prevent from undesirably removing flexible sleeve main body 226 (Fig. 6) from most advanced and sophisticated 228.

Structurally, ring 256 and barb 260 advantageously can be molded as a part of most advanced and sophisticated 228.Alternatively, after structure most advanced and sophisticated 228, ring 256 is by swaged forging or curlingly put in place.In certain embodiments, ring 256 is optionally made up of radiopaque material, such as with contribute to through in every the location of cannula assembly 224 (Fig. 6).Alternatively, independent radiopaque band (not shown) can be constructed and enough place close to ring 256.

Forward now Fig. 8 A-8E to, explain the details every the anchoring piece 230,232 of cannula assembly in warp in more detail.Specifically illustrate in fig. 8 a, each anchoring piece 230,232 comprises the multiple pillars 234 extended from centering ring portion 262.Multiple pillar 234 and central annular portion 262 can be etched into individual unit from same elastic material, to form the inner supporting structure for each anchoring piece 230,232.Alternatively, each pillar 234 for good and all can be fixed to the central annular portion 262 manufactured separately, such as, by welding or other means.Should be understood that, although illustrate that each anchoring piece 230,232 has four pillars 234, this quantity is not limited in this.On the contrary, in the embodiment that can be susceptible to, for concrete surgical needs or hobby, may need or expect less or more pillar 234.There is provided at least three pillars to cause implant the more high stability of most advanced and sophisticated 228 (Fig. 7 B).

Pillar 234 and ring portion 262 are made up of super-elastic NiTi material at least in part by following, namely by the part of the smooth sheet stock of chemical etching, the part that electrobrightening etches, to remove the Roughen Edges produced in forming process, then heats this part to superelastic.Although explained preferred material specially herein, for most advanced and sophisticated or anchoring piece, other suitable biocompatibility, non-conforming type, flexible material will be enough.

Fig. 8 B illustrates anchoring piece 230 by some details, and 232 also comprise porous polymer structure 236.Functionally, this porous polymer structure 236 provide the surface larger than only multiple pillar 234 to engage described in every (not shown).In addition, porous polymer structure 236 allows tissue ingrowth, wherein from every tissue can grow and be embedded in porous polymer structure 236, to provide higher structural stability and sealability.Although one or two anchoring piece 230,232 can comprise porous polymer structure 236, but usually preferably only have the second anchoring piece 232 (its will along in reside in right atrium (not shown) every (not shown)) will comprise porous polymer structure 236.This configuration is preferred, because right atrium is greater than left atrium on volume; But the present invention should not be regarded as being limited to this.

The suitable material being suitable for porous polymer structure 236 can include but not limited to monofilament polyester or polyfilament yarn; EPTFE monofilament or polyfilament yarn; Or fluorinated polyolefin fiber or yarn, it can be weaving, braiding, knitting or felting becomes suitable configuration.This porous polymer structure 236 can also comprise various intrinsic configuration, comprises the yarn fabric with two dimension or three-dimensional honeycomb body, circle, flat or three axle tubular structures, fabric, or knitted fabric.In other embodiments, porous polymer structure 236 can be formed by for tubulose, ePTFE sheet material that is cylindrical or sheet form.Typically, porous polymer structure 236 forms going out certain shape to construct from two panels raw material (all described above those) by etching or cut.Then the polymer architecture 236 of shaping is ultrasonically bonded to together, makes the polymer architecture of described shaping catch anchoring piece therebetween.

As shown in Fig. 8 B further, each pillar 234 can comprise labelling 264.Labelling 264 can be formed from fluorescent paint, makes the position by the visible anchoring piece 230,232 of intracardiac ultrasoundcardiogram.By this way, labelling 264 makes surgeon by the anchoring piece 230,232 of longitudinal center's axis that is parallel to representated by line 138 from the anchoring piece 230 transverse to same axis, can distinguish between 232.Therefore, surgeon can determine the first and second anchors 230,232 deployed condition in vivo.Other the suitable material being suitable for above-mentioned labelling 264 can comprise radiopaque or similar material.

Fig. 8 C illustrates disposed anchoring piece 230,232 with side view.Described multiple pillar 234 makes anchoring piece 230, and 232 have slight recessed curvature.Because likely change from patient to patient every the actual size of (or interatrial septum), shape and structure in heart and atrium, in sensing every this slight sag vertical curve allow to be designed to be applicable to anatomical structure widely every cannula assembly in single warp.In addition, slight curve provide centering every larger elastic clamping effect.

Fig. 8 D-8E illustrates anchoring piece 230, and 232 can be located so that the first anchoring piece 230 offsets relative to the second anchoring piece 232.Due to specific load-bearing benefit, this is the preferred disposition of disposed anchoring piece 230,232.But, if needed especially, comprise and do not have the anchoring piece offset will to be also possible.In addition, the first anchoring piece 230 can be greater than to provide the mode of larger contact surface area to build anchoring piece 230,232 with the second anchoring piece 232, as seen in fig. 8e.This configures than opposite resolution preferably, because right atrium is greater than left atrium on volume; But the present invention should not be regarded as being limited to this.Such as, in certain embodiments, preferably the first anchoring piece 230 may only be comprised on most advanced and sophisticated 228.In this embodiment, the first anchoring piece can comprise porous polymer structure 236, or can keep exposed.

As seen in fig. 8e, slight sag vertical curve can cause the first and second anchoring pieces 230,232 to intersect with the deployed condition of its free-standing when being installed to most advanced and sophisticated 228 (Fig. 6) and being upper.

Because anchoring piece is in its natural state transverse to longitudinal center's axis, is necessary anchoring piece to fold into and is roughly parallel to longitudinal center's axis and is suitable for the position that is loaded into by anchoring piece in delivery sheath.

Fig. 9 A and 9B illustrates for being loaded into the sleeve pipe loading attachment 266 in delivery apparatus 208 as shown in Figure 6 by warp every cannula assembly 224.Sleeve pipe loading attachment 266 is included in the plunger 268 in plunger housing 270.Plunger 268 comprises major diameter part 272 and small diameter portion 274.Small diameter portion 274 receives spring 276.The near-end of plunger 268 can comprise female thread 279 (Fig. 9 B), and for receiving screw 280 and packing ring 282, thus keep-spring 276 is positioned in minor diameter 274.

Fig. 9 A-9B and 10A-10D illustrates the far-end of plunger housing 270, and it comprises multiple groove 286 and multiple finger piece 288.The number of groove 286 is consistent with the number of the pillar 234 of the first anchoring piece 230; The number of finger piece 288 is consistent with the number of the pillar 234 of the second anchoring piece 232.Plunger housing 270 also comprises the first and second end differences 290,292 being positioned at inside, and wherein the first end difference 290 is positioned at the nearside of described second end difference 292.

In operation, and as shown in Figure 10 A-10D, utilize most advanced and sophisticated 228 to guide every cannula assembly 224 in warp and be inserted in the far-end 284 of plunger housing 270, make the pillar 234 of the first anchoring piece 230 aim at multiple groove 286, thus keep in the deployed state, as shown in FIG. 10A.When most advanced and sophisticated 228 are positioned at plunger housing 270 further, each pillar 234 of the second anchoring piece 232 is aimed to each in multiple finger piece 288 and the second corresponding end difference 292, thus under making each pillar 234 of the second anchoring piece 232 fold into contraction state, namely diameter is less than the internal diameter of delivery sheath 210.

From Fig. 9 A-9B and 10A-10D, should be understood that, the relative position of the first and second end differences 290,292 can contribute to determining through in the degree of depth that will be inserted in delivery sheath 210 every cannula assembly 224.Such as, if the second end difference 292 is positioned near described first end difference 290, then the major part of delivery sheath 210 will be inserted on the second anchoring piece 232.Contrary scheme also will be like this.Therefore, when depression of plunger 268, in warp, delivery sheath 210 will be positioned at further every cannula assembly 224.

Now concrete with reference to Figure 10 A and 10B, once through in be fully inserted into plunger housing 270 in (namely the first anchoring piece 230 contacts the first end difference 290) and flexible sleeve main body 226 distad extends from sleeve pipe loading attachment 266 every the tip 228 of cannula assembly 224, delivery sheath 210 can be directed in flexible sleeve main body 226 and upwards arrival second-order ladder portion 292.Because the second anchoring piece 232 deflected (as shown in the figure) is to the diameter being less than described delivery sheath 210 internal diameter, delivery sheath 210 can be passed through to contact with the second end difference 292 between the second anchoring piece 232 and multiple finger piece 288.

Figure 10 C-10D illustrate by by tip 228 from sleeve pipe loading attachment 266 be delivered to delivery sheath 210 and will through be loaded in delivery sheath 210 every cannula assembly 224.Then the screw 280 (Fig. 9 B) of surgeon's plunger depressed 268 near-end 278 (Fig. 9 B), thus by pressing spring 276 (Fig. 9 B), the major diameter part 272 of plunger 268 is advanced on the direction of arrow 294.After plunger 268 contacts with most advanced and sophisticated 228, on the direction of arrow 294, further plunger depressed 268 will cause described second anchoring piece 232 to enter delivery sheath 210, as shown in figure 10 c.The further movement of plunger 268 will cause most advanced and sophisticated 228 to enter delivery sheath 210 and start the folding of the first anchoring piece 230, as shown in fig. 10d.

Arrive its stroke end once plunger 268, will be loaded onto in delivery sheath 210 in warp every cannula assembly 224, the second anchoring piece 232 is deflected and proximad extension, the first anchoring piece 230 deflects and also distad extends simultaneously.When spring 276 (Fig. 9 B) is released, plunger 268 will turn back to resting position and be removed every cannula assembly 224 and delivery sheath 210 from warp by sleeve pipe loading attachment 266.

Figure 11 illustrates and the substituting delivery apparatus 296 used together with cannula assembly in warp.Described delivery apparatus 296 comprises delivery sheath 298 and is positioned at the wheel hub 300 of nearside, such as haemostatic valve.Wheel hub 300 also can comprise the lateral port 306 with pipe 308 and the valve 310 entered for fluid.To open haemostatic valve and to allow occluder 311 to extend through delivery sheath 298 in the near-end that removable loading pipe 302 is pressed into wheel hub 300, for expand by during line 138 is in atrium every the interior opening 311 formed.Occluder 311 and loading pipe 302 were removed in loading warp before cannula assembly (not shown).Finally, the indicia band 313 being positioned at distally is used in body inner position.

Figure 11 B illustrate use nearside loading attachment 312 will through in be loaded in delivery apparatus 296 every cannula assembly 224.Nearside loading attachment 312 comprises tubular construction 314 and handle 316, and described tubular construction 314 is preferably made up of ePTFE or FEP, and handle 316 is made up of to assist surgeon to handle and dock nearside loading attachment 312 and delivery apparatus stiff materials.Suitable material for handle 316 can comprise acrylonitrile-butadiene-styrene (ABS) (ABS) or Merlon.Although do not specifically illustrate in Figure 11 B, handle 316 can comprise ring near and along the circumferential direction around the bonding ring of described tubular construction 314 with for injecting the access interface being suitable for described handle 316 being connected to the binding agent of tubular construction 314.Also alternative handle 316 and tubular construction 314 combined can be used.

Continue with reference to Figure 11 B, nearside loading attachment 312 docks with delivery sheath 298 (Figure 11 A) at wheel hub 300 place by surgeon.Wheel hub 300 comprises O shape ring 318, and it is as a part for the haemostatic valve of the fluid-tight seal that can be formed around delivery sheath 298.Transition point 322 between the tubular construction 314 and delivery sheath 298 of near-end loading attachment 312 should not interrupt making substantially, make through in every cannula assembly 224 proximally loading attachment 312 steadily and be freely manoeuvred in delivery apparatus.Then can complete and be delivered to delivery apparatus by warp every cannula assembly 224 by pressing flexible sleeve main body 226 in the distal direction shown in arrow 324.

Forward now Figure 12 A-12D to, once be loaded onto in delivery sheath 298 every cannula assembly 224 in warp, surgeon is by having loaded foley's tube 238 every the portions of proximal back side of cannula assembly 224 in warp.Then foley's tube 238 is positioned at most advanced and sophisticated 228 indicia band 251 is aimed at the far-end of delivery sheath 298.Then fluid expansion sacculus 240 (Figure 12 A) is used, the saline of fluid normally with or without contrast agent.When fully expanding, the distal radial of sacculus 240 expands more than the first anchoring piece 230 and is engaged by the internal diameter of the internal diameter of delivery sheath 210 with tip 228, thus fixing tip 228 and delivery sheath 210.

Foley's tube 238, through in advance to secondary cutting part 182 (Fig. 5) on then cannula assembly 224 and delivery apparatus 208 the are positioned at line 138 near-end (not shown) as a unit.Delivery apparatus 208 along line 138 by right clavicle 112 (Fig. 5), superior vena cava 116 (Fig. 5), and will enter in right atrium 117 (Fig. 5) every cannula assembly 224 and foley's tube 238 together with in warp.

As shown in figure 12a, once be positioned at right atrium 117 every cannula assembly 224 in delivery apparatus 208 and warp, surgeon can make delivery apparatus 208 enter on line 138 as a cell row every cannula assembly 224 and foley's tube 238 together with in warp, the proximal tapered 325 of the sacculus 240 expanded is expanded and passes in atrium by line 138 opening formed every 102.

Proceed to now Figure 12 B, wherein expanded by the opening every 102 in atrium and delivery apparatus 208 travel across in the directions of the arrows expansion opening by atrium every 102.Therefore, the far-end 228c at sacculus 240, first anchoring piece 230 and tip 228 resides in left atrium 132.Surgeon then deflated balloon 240 also aims at sacculus 240 and most advanced and sophisticated 228 again by indicia band 251 (Figure 12 A) being aimed at the labelling (not shown) on most advanced and sophisticated 228.Then sacculus 240 is re-inflated so that the internal diameter of engaging tip 228, allows the relative movement between most advanced and sophisticated 228 and delivery sheath 210 simultaneously.

In Figure 12 B, surgeon makes foley's tube 238 advance, and wherein most advanced and sophisticated 228 exceed delivery sheath 210, make the first anchoring piece 230 be moved beyond delivery sheath 210 and enter in left atrium 132.By this way, the first anchoring piece 230 launches (spring is outside) to deployed condition (illustrating with solid line) from contraction state (shown in broken lines) in left atrium 132.Second anchoring piece 232 keeps in a contracted state and is in delivery sheath 210.Foley's tube 238 then regracting, thus retract most advanced and sophisticated 228, and make the first anchoring piece 230 with in atrium in contact every 102.

Figure 12 C illustrates that foley's tube 238 is retracted together with most advanced and sophisticated 228 and delivery sheath 210, until the first anchoring piece 230 launched with in the atrium in left atrium 132 in contact every 102.

Finally, as seen in fig. 12d, surgeon continues retraction delivery sheath in the direction of the arrow 210, under foley's tube 238 and most advanced and sophisticated 228 remains on appropriate location simultaneously.Second anchoring piece 232 is deployed into expanded position (illustrating with solid line in fig. 12d) from punctured position (illustrate with solid line among Figure 12 A-12C and shown in broken lines in fig. 12d) in the mode being similar to the first anchoring piece 230 by this.Second anchoring piece 232 of this expansion engages in the atrium in right atrium 117 every 102.Meanwhile, the first and second anchoring pieces 230,232 will move every 102 preventing tip in atrium.

Now, tip 228 and anchoring piece 230,232 are implanted in atrium on the opposite flank of 102, and then delivery sheath 210 can remove from secondary cutting part 182 (Fig. 5).Sacculus 240 is reduced again and foley's tube 238 removes from secondary cutting part 182 (Fig. 5).Finally, anchoring director element is retracted by line 138 and removes, simultaneously keep through in every the position of cannula assembly 224, thus make ring 162 (Fig. 5) or other anchorage part be folded and arranged in the previously described manner through in every cannula assembly 224.Anchoring director element completely remove after, only have through in remain on original position every cannula assembly 224.

In implantation warp in the alternative method of cannula assembly (it is not shown in figures), by in atrium every opening rely on removable occluder or foley's tube to be expanded in advance, it expands the diameter approximating greatly delivery sheath external diameter to.Suitable removable occluder can comprise bar and the expansion on occluder far-end.Although occluder is preferably by nylon 11, nylon 12, or PEBAX makes, and other suitable material is also suitable.This bar can comprise contiguous expansion and the indicia band of aiming at delivery sheath.Indicia band can be made up of any material, its by make surgeon can remotely determine the far-end of delivery sheath in heart position.Surgeon can make occluder to advance on seal wire and enter right atrium.The continuing to advance of the distal end taper body of occluder or foley's tube has been expanded in atrium every interior opening.When occluder is retracted from secondary cutting part, in do not rebound immediately every interior opening, but still slightly stretch, this more easily receives the delivery sheath having foley's tube as above or do not have foley's tube.

In implantation warp in the another method of cannula assembly, the foley's tube described before surgeon can be included in and be different from a way.That is, sacculus shape conduit be inserted into through in cannula assembly, simultaneously sacculus is in contracted position.Once through in be in left atrium and first delivery sheath is contracted every the distal part at the tip of cannula assembly, foley's tube expands simultaneously.Delivery sheath makes the compound action of balloon catheter expansion to guarantee while retracting, and any anchoring piece as herein described appropriately and fully launches.

Implant according to one of previously described method through in every cannula assembly and all auxiliary device (i.e. seal wire, delivery apparatus, foley's tube, occluder etc.) from after secondary cutting part removes, circulatory assit system can be implanted.

Figure 13 illustrate with in warp every the implanted circulatory assit system 334 that cannula assembly 224 associates.In this respect, flexible sleeve main body 226 (its usually in atrium extend to secondary cutting part 111 via superior vena cava 116 and right subclavian vein 112 every 102) is cut into suitable length, and is attached to the input port 336 of implantable pump 338.Independent outflow sleeve pipe 340 is attached to the output port 342 of described implantable pump 338, and then described output port 342 is attached by surgical operation to be communicated with suitable shallow artery (such as right subclavian artery 344).Now, implantable pump 338 keeps pump 338 in outside by being arranged under subcutaneous or muscle in secondary cutting part 111 or even by surgeon after secondary cutting part 111 is closed.

Also as shown in Figure 13, pump 338 is operationally associated with controller 346, and described controller also can be implanted or to remain on patient 108 external.Signal transmitting apparatus 348 is provided between pump 338 and controller 346 and can be hardwired or Wireless Telecom Equipment.In operation, the pump action of controller 346 scalable pump 338.In addition, memory devices 350 can be included in controller 346, and it is movable so that doctor's assessment subsequently and interaction that it will record pump.

Alternatively, also as shown in Figure 13, when only using the first anchoring piece on most advanced and sophisticated 228, hemostatic sleeve belt 351 (shown in broken lines) can be used as the second anchoring piece, and can prevent through in distad move every cannula assembly 224.Hemostatic sleeve belt 351 provides the sealing member every cannula assembly 224 in warp at the wall place of right subclavian vein 112.Structurally, hemostatic sleeve belt 351 can be made up of elastomeric material, such as collagen protein, and it will expand when contacting with fluid (such as blood).

According to preferred embodiment and complete blood flow as shown in Figure 13 as follows: oxygenated blood will to be advanced in left ventricle 352 via natural route from left atrium 132 and to arrive aorta 354.From aorta 354, blood moves to left subclavian artery 356, left common carotid artery 358, and brachiocephalic trunk 360.Oxygenated blood also will from left atrium 132 enter through every cannula assembly 224.Blood will enter flexible sleeve main body 226, and the inner chamber being advanced through flexible sleeve main body 226 arrives pump 338.Blood pump is delivered to and is flowed out in sleeve pipe 340 and enter in right subclavian artery 344 by pump 338 on one's own initiative.From here, blood is directed into the remainder of blood vessel network.

In a substituting embodiment, as shown in Figure 14, have nearside, the tip 362 of centre and distal part 362a-c can comprise anchoring piece, it is configured on distal part 362c, have screw thread-like 364.By this way, surgeon by rotating tip 362 by atrium every (not shown), make the continuous rotary screwing thread of anchoring piece by combining every wall.Portions of proximal 362a can comprise for be attached through in every the barb 366 of the flexible sleeve main body 226 (Fig. 6) of cannula assembly 224 (Fig. 6).Although the present embodiment illustrates in an independent way, most advanced and sophisticated 362 can use together with any extensible anchoring piece embodiment as herein described.

Figure 15, Figure 16 A and 16B illustrates the alternative of two kinds of versions of tip and anchoring piece.Particularly, Figure 15 illustrates the tip 368 with nearside, centre and distal part 386a-c, and it has the anchoring piece 370 that formed on near-end 368a and comprises first group and second group of pillar 372,374 extending from single middle body 376.This single middle body 376 allows the pillar 372 of anchoring piece 370, and 374 are configured to double surface unit.In this replacement scheme, still in right atrium 117 (Figure 12 D), it is configured to be greater than pillar 372 pillar 374.Pillar 372,374 is elongated to increase every 102 (Figure 12 D) and pillars 372 in atrium, the contact surface area between 374, and not necessarily comprises the porous polymer structure covering pillar 372,374.

But, as shown in Figure 15, when need the benefit of porous polymer structure but limited space time, will allow to comprise the less ring 378 of the porous polymer structure with most advanced and sophisticated 368.The ring 378 of this porous polymer structure can work in the previously described manner, and namely surface is suitable for tissue ingrowth, but does not increase the size of anchoring piece 370.Far-end 368c can be configured as and comprise flared part 380 to be defined for the mounting groove 382 of the ring 378 receiving porous polymer structure.Therefore, when assembling most advanced and sophisticated 368, ring 378 and the single middle body 376 of porous polymer structure are fixed in mounting groove 382 by being pressed together by each assembly.Alternatively, most advanced and sophisticated 368, the ring 378 of porous polymer structure and anchoring piece 370 are fixed by welding or other suitable mode.

Another embodiment is as shown in figures 16 a and 16b the tip 384 with nearside, centre and distal part 384a-c, and comprises one side anchoring piece 386, and described one side anchoring piece has the multiple paddle pillars 388 extended from middle body 390.Paddle pillar 388 is deployed in left atrium (not shown).Multiple paddle pillar 388 provides the additional surface contact area between each pillar in atrium in 102 (Figure 12 D) and described multiple paddle pillar 388.Although directly do not illustrate, Figure 15 can be similar to and build two-sided anchoring piece like that, but it has multiple paddle pillar 388.Therefore, the shape of pillar can change according to specific operation needs, and described needs need not be limited to shown in this article those.

Figure 16 A and Figure 16 B illustrates the ring 392 of porous polymer structure, and it is similar to foregoing ring, but larger on surface area.In this aspect, the far-end 384c of most advanced and sophisticated 384 can comprise the flared part 394 of expansion, to form surface 396 for the middle body 390 of the ring 392 and anchoring piece 386 engaging porous polymer structure and mounting groove 398.The flared part 394 of this expansion provides larger stability and support can to the ring 392 of porous polymer structure, in addition, also can allow the ring 392 of porous polymer structure to be adhered to surface 396 to obtain even larger stability.

Figure 16 B illustrates further in ring 392 part by the porous polymer structure in engaging atrial between each pillar of multiple paddle pillars 388 of 102.

In another alternate embodiment, as shown in Figure 17, flexible sleeve main body 400 can be included in the first and second control lines 402,404 on near-end 406.Control line 402,404 allows the position of surgeon's retentive control flexible sleeve main body 400, thus when delivery sheath 210 (Fig. 6) is removed from secondary cutting part, most advanced and sophisticated 228 (Fig. 6) are in patient's heart.As shown in the figure, the first and second control lines 402,404 can be made up of rustless steel, and can weave further (as in figure shown in 408) to increase the strength and stability of each control line 402,404.The total length of control line 402,404 such as can make the total length of flexible sleeve main body 400 extend at least 1.5 times of delivery sheath 210 (Fig. 6) length.This will guarantee that surgeon controls the position every cannula assembly in warp in surgery perioperative any time.

Also figure 17 illustrates indicia band 410, the near-end 406 near flexible sleeve main body 400 can be placed on, to monitor the position of flexible sleeve main body 400 in vivo.Indicia band 410 can be made by being similar to those radiopaque materials previously described.

In other embodiments, described flexible sleeve main body 400 can comprise coil 412 at least partially, to strengthen the flexible sleeve main body 400 be molded.The material being suitable for coil 412 can comprise high resiliency or hyperelastic metal, comprises the stainless steel silk of NiTi or spring temper.

In operation, when surgeon retracts delivery sheath so that when launching or retract from secondary cutting part completely, surgeon catches the control line 402,404 of flexible sleeve main body 400.By this way, when delivery sheath is retracted, every interior position in can keeping described tip, anchoring piece and flexible sleeve main body 400 in atrium.

In yet another embodiment, delivery apparatus can comprise the sheath be made up of release liner.By this way, in warp after cannula assembly is properly inserted into, sheath is separated and remove.

Finally, Figure 18 A and Figure 18 B illustrates another embodiment (also see Fig. 4 D), it is for the expansion of piggy-back anchor firmware, delivery sheath can replace with blocking sheath 414, block sheath 414 to be configured to only cover most advanced and sophisticated 228 (Fig. 6) and anchoring piece (only the first anchoring piece 230 is illustrated), thus do not extend the whole length of flexible sleeve main body 226.Block sheath 414 and extend to secondary cutting part 111 (Figure 1A) by least one control line 416 proximad.By this way, surgeon can move by pulling control line 416 to make to block sheath 414, thus launches anchoring piece to be similar to previously described mode.Be particularly conducive to the present embodiment, compared with allowing with previously described delivery sheath, surgeon can have larger control force in maintenance warp every the position of cannula assembly 224.In itself, most of length of delivery sheath 210 is replaced by one or more control line 416, and in spare-part surgery operation process, it more easily allows blood to continue flowing every cannula assembly in warp.

With reference to Figure 19 A-19B, the alternative every cannula assembly 500 in the warp of circulatory assit system is shown.The casing main body 502 with near-end 504, far-end 506 and inner chamber therebetween 508 is comprised every cannula assembly 500 in warp.Casing main body 502 can comprise and strengthens part 510, as shown in the coil 512 that configured by the length at least partially along casing main body 502.In an alternative embodiment, be not the circular cross section had as shown in figure 19, but coil 512 can have substantially rectangular cross section (not shown), thus decrease the cross-sectional area of coil 512.This configuration of coil 512 can advantageously provide the reduction on the whole cross-sectional area of casing main body 502.

Tip 514 is connected to the far-end 506 of casing main body 502, and described tip comprises the opening 516 be communicated with the inner chamber 508 of casing main body 502.More specifically, most advanced and sophisticated 514 casing main body 502 is connected to by interference fit.Barb 538 (Figure 22) can provide resistance to remove from tip 514 is unwanted to prevent casing main body 502.Most advanced and sophisticated 514 also can preferably include anchoring piece 518a, 518b.

Inner chamber 508 has the first internal diameter 519a at near-end 504 place and the second internal diameter 519b at far-end 506 place.First internal diameter 519a is greater than the second internal diameter 519b, thus is limited to the conical section 520 in inner chamber 508.When blood pressure reduces from the far-end 506 of cannula assembly 500 to near-end 504, when blood to extract from the chamber of heart 15 and is directed in the blood circulation (Figure 23 A to 23B) of patient 14, conical section 520 is configured to anti-Hemostatic Oral Liquid cavitation in inner chamber 508.

More specifically, inner chamber 508 comprises the first internal diameter 519a along inner chamber 508 portions of proximal 522.First internal diameter 519a keeps constant along portions of proximal 522.In one embodiment, along the first internal diameter 519a of portions of proximal 522 be about 5.75 to about 5.8mm.Conical section 520 in inner chamber 508 is restricted to stepped conical section, makes the office, start portion in conical section 524, and the internal diameter of inner chamber 508 is about 5.75 to about 5.8mm.At terminal 526 place of conical section 524, the internal diameter of inner chamber 508 is about 5mm.Then continue distally part 528, the internal diameter of inner chamber 508 is that about 5mm is until the far-end 506 of casing main body 502.In a preferred embodiment, casing main body 502 and inner chamber 508 have the length of about 290mm.In inner chamber 508, portions of proximal 522 has the length of about 190mm, and conical section 520 has the length of about 30mm, and distal part 528 has the length of about 70mm.In this embodiment, the conical section 520 provided in inner chamber 508 causes when blood advances to near-end 504 from the cardiac chambers of the far-end 506 of casing main body 502, the pressure loss has the improvement of 25% (inner chamber relative to having constant diameter), and wherein casing main body 502 is communicated with the blood circulation of patient.

In a substituting embodiment, inner chamber 508 can be provided with the conical section 520 of alternate configuration.Instead of discuss about Figure 19 A-19B there is stair-stepping conical section, conical section 520 can be restricted to the constant taper between the first internal diameter 519a and the second internal diameter 519b of far-end 506 of near-end 504.Further alternatively, inner chamber 508 can be included in the more than one stepped conical section between proximal part 504 and distal portions 506, and it is configured to reduce the pressure loss and prevents the distally 506 blood cavitations advancing to near-end 504.In addition, above these sizes disclosed specific to the above embodiments, but and do not mean that the restriction disclosure.

With reference to Figure 20, can be conducive to provide the tip 514 of cannula assembly 500, it has the feature of the blood flowing characteristic improving cannula assembly 500.Most advanced and sophisticated 514 comprise near-end 514a, far-end 514b and main body therebetween 517.Most advanced and sophisticated 514 comprise the inwall 529a limiting inner chamber 529b, and it comprises some size of the fluid flowing providing favourable.In this respect, as shown in Figure 20, the distal part 515 of most advanced and sophisticated 514 comprises first and second ends 530,532 respectively with first and second internal diameter 534a, 534b.The second end 532 is more farther than first end 530, and the second internal diameter 534b is greater than the first internal diameter 534a.In an embodiment of most advanced and sophisticated 514, the difference of first and second internal diameter 534a, 534b by most advanced and sophisticated 514 be defined as roughly mitriform or bell shaped members at least partially.More specifically, most advanced and sophisticated 514 comprise the first end 530 with the first internal diameter 534a and the second end 532 with the second internal diameter 534b.Roughly curved portion 536 between the first and second ends 530,532, thus by roughly bell for most advanced and sophisticated 514 be defined as at least partially.As shown in the figure, the near-end 514a of most advanced and sophisticated 514 also comprises the mitriform part of analogous shape.

The benefit that the mitriform shape of most advanced and sophisticated 514 provides fluid to flow to circulatory assit system.More specifically, mitriform shape provides more level and smooth transition flow, thus reduces the pressure loss, because fluid is manoeuvred in less tip 514 and casing main body 517 from larger heart chamber.Minimizing enters the most advanced and sophisticated fluid of 514 or the pressure loss of blood provides more favourable circulatory assit system.In addition, advantageously, when blood draw is to inner chamber 508, mitriform shape reduces blood in most advanced and sophisticated 514 places and the probability that turbulent flow occurs in sleeve pipe 502, thus increases whole efficiency and the effectiveness of system.

Common bell most advanced and sophisticated 514 can not have and may cause thrombotic defect.Such as, most advanced and sophisticated 514 can be polished, may cause thrombotic any defect to remove.In addition, the transition between casing main body 502 and most advanced and sophisticated 514 can be level and smooth and not have to cause the uneven of thrombosis.

With further reference to Figure 20, most advanced and sophisticated 514 can be included in the one or more barbs 538 on the near-end 514a of most advanced and sophisticated 514 further.Barb 538 provides resistance to prevent from removing casing main body 502 from tip 514 is unwanted.Except barb, swaged forging or crimp band 540 can be arranged on casing main body 502, prevent from removing casing main body 502 from the unwanted of tip 514 to provide further resistance.Swaged forging or crimp band 540 can be made up of malleable material (such as tantalum), to adapt to casing main body 502 larger fluctuation dimensionally.Advantageously, if needed, if be made up of radiopaque material (such as tantalum), then swaged forging or crimp band 540 can be used as fluorography label.

Continue with reference to Figure 20, most advanced and sophisticated 514 can comprise one or more ring 539 further, provide described ring for possible several reasons.Such as, the mode that these rings 539 can engage anchoring piece 518a, 518b works.Advantageously, ring 539 can be provided with porous polymer structure 541 (such as polyester textile), wherein from every tissue can grow and be embedded in porous polymer structure 541 to provide higher structural stability.The far-end 506 of casing main body 502 can adjoin one of anchoring piece 518 substantially.In addition, additional ring 537 can be included and can be used for settling anchoring piece 518a, 518b, and to a certain extent can by keying to keep the direction of described anchoring piece 518a, 518b.

In one embodiment, tip body 517 is made up of titanium alloy (such as TiAI6VaEL1) by standard turning, line electrode electric discharge processing (EDM) or other processing technique.In this respect, and as being clearly shown that in the viewgraph of cross-section of Figure 20, most advanced and sophisticated 514 is integrally-built rigidity tips 514.

Figure 21 A-C illustrates the alternate embodiment of delivery sheath 542.Delivery sheath 542 also comprises far-end 544, near-end 546 and main body therebetween 548.Main body comprises inwall 549a and outer wall 549b.Inwall 549a is defined for the passage or inner chamber 549c of receiving cannula assembly 500.Delivery sheath 542 comprises wheel hub 543, and it is operably connected to piping 545 at near-end 546 place, and described piping 545 can be connected to air source or the ventilation for wheel hub 543 or delivery sheath 542.Due to the material behavior of delivery sheath 542, in cannula assembly 500 is delivered to every process in move relative to delivery sheath 542 when cannula assembly 500 time, delivery sheath 542 is easily deformable on the moving direction of cannula assembly 500.When making casing anchor firmware 518 advance to leave most advanced and sophisticated 514, the plastic deformation of sheath 542 is disadvantageous, and then this rebound in uncontrolled mode because delivery sheath 542 can stretch when proximal anchors is left.Sheath shows in this manner and may by mistake make distal anchors 518b launch in left atrium.Tensile elements 550 is used for preventing this situation, therefore, gives doctor to the accurate control at sheath tip 514 when launching each anchoring piece 518a, 518b.

As shown in figure 21 a, delivery sheath 542 comprises the tensile elements 550 being arranged at the longitudinal direction between inner and outer wall 549a, 549b and arranging.Tensile elements 550 can prevent as above stretching and rebounding subsequently, and therefore gives doctor when launching every suit anchoring piece 518a, 518b to the accurate control at sheath tip 514.But in substituting embodiment, delivery sheath 542 can have more tensile elements 550.Such as, the main body 548 of delivery sheath 542 can have at least two or more tensile elements 550, is preferably equally spaced.Tensile elements 550 can be flexible, makes it not damage the flexural property of sheath 542.Therefore tensile elements 550 can comprise the material being configured to provide flexural property needed for described sheath 542.Preferably, tensile elements 550 comprises monofilament or the multifilament of polymeric material.More specifically, tensile elements can comprise multifilament, and it can comprise the polymeric material being wound around or weaving.Tensile elements 550 can be embedded in the main body 548 of delivery sheath 542, and tensile elements 550 is arranged between the inwall 549a of main body and outer wall 549b.Tensile elements 550 can be embedded in the main body 548 between inwall 549a and outer wall 549b by this mode of various manufacture method.In one embodiment, under tensile elements 550 utilizes the groove on the every one end of the axle of sheath 542 to remain in tension force.Reflux process adopts PEP (FEP) as compression material, time more than the melt temperature being heated to material between the inwall 549a of main body and outer wall 549b, it allows element to be encapsulated between inwall 549a and coil 555 and outer body 549b.

Alternatively, other manufacturing mode is possible and will will be apparent for a person skilled in the art.Except tensile elements 550, delivery sheath 542 can comprise enhancing structure (such as coil 555), subsides between its operating period to prevent delivery sheath 542.

Wheel hub 543 comprises the distally main seal 556 with slit 557 and the nearside secondary seal 558 with hole 559.Arrange multiple sealing member to be allowed for hemostatic seal, wherein the device of different size is directed in wheel hub 543 and delivery sheath 542.In one embodiment, proximal seal has 0.050 " width, and distal seal has 0.25 " width.Multistage dense sealing is suitable for seal wire (it can have 0.035 " external diameter) until casing main body (it can have up to 0.5 " and even can be greater than 0.5 " external diameter) hemostatic seal is provided.Piping 545 is in the distally of the main of end difference 574 distal position place and secondary seal 556,558.Piping 545 is placed on the distally of sealing member 556,558 to allow the hemostatic seal in wheel hub 543 keeping system, ventilates to delivery sheath 548 simultaneously.Piping 545 also can be used for fluid to guide to enter in system.

In one embodiment, wheel hub 543 comprises the multipart molectron 560 with distal part 562 and portions of proximal 564.Distal part 562 comprises main seal 556 and is connected to delivery sheath 542 securely.Distal part 562 comprises and is configured to receive described portions of proximal 564 and keeps portions of proximal 564 relative to the part 566 of its position.In one embodiment, distal part 562 and portions of proximal 564 comprise threaded portion 568, together with described threaded portion 568 is threadedly engaged and is connected to portions of proximal 562,564 in distally thus, and keep portions of proximal 564 relative to the position of distal part 562.

Wheel hub 543 is included in the first internal diameter 570 that portions of proximal 564 place has the size receiving loading attachment 578 (Figure 22 A).The distal part 562 of wheel hub 543 comprises second internal diameter 572 with the size receiving described loading attachment 578.The distal part 562 of wheel hub 543 comprises end difference 574, and it is restricted to the transition portion between second internal diameter 572 and the 3rd internal diameter 576 of wheel hub.3rd internal diameter 576 is identical or similar with the internal diameter 586 (Figure 22 A) of loading attachment 578, makes anchor 518a, 518b keep folding when leaving from loading attachment 578 in the distal part 562 being directed into wheel hub 543 simultaneously.

Figure 22 A illustrates the alternate configuration of the charger 578 of delivery system as discussed herein.In the embodiment shown in Figure 22 A, charger 578 is configured to receive anchoring piece 518a, 518b of being under contraction state, and assist cannula assembly 500 to be delivered in delivery sheath 542, wherein anchoring piece 518a, under 518b is in contraction state simultaneously.

Loading attachment 578 comprises far-end 580, near-end 582 and inner chamber therebetween 584.Far-end 580 has the first internal diameter 586 and near-end 582 has the second internal diameter 588.First internal diameter 586 is less than the second internal diameter 588, thus between the far-end 580 and near-end 582 of inner chamber 584, limits the stepped part 590a in inner side and outer side, 590b respectively in inner chamber 584 and on Outboard Sections 591.The stepped part 590a in inner side comprises conical section 592, and when loading attachment 578 reception is in the anchoring piece 518 under contraction state, it is configured to prevent from damaging anchoring piece 518.

This loading attachment 578 is for folding anchor firmware 518a, 518b and cannula assembly 500 be incorporated in the wheel hub 543 of delivery sheath 542.In order to folding anchor firmware 518a, 518b, cannula tip 514 advances to and passes through loading attachment 578 as shown in Figure 22 B, thus folds two fixing plate 518a, 518b in a proximal direction.As shown in Figure 22 C, distal anchors 518b is allowed to leave the far-end 580 of loading attachment 578, until they extend.Then cannula assembly 500 retracts in a proximal direction slightly distad to fold distal anchors 518b and to make proximal anchors 518A proximad fold.Then loading attachment 578 is inserted in sheath wheel hub 543 (Figure 22 E) by main and secondary seal 557,558 and also keeps engaging with wheel hub 543, until the tip 514 of cannula assembly 500 passes laterally through distally main seal 557.Loading attachment 578 is removed and sealing member 557,558 is provided in the hemostatic seal on casing main body 502.The internal diameter of delivery sheath 542 can or basic simlarity identical with the internal diameter 586 of loading attachment 578, to guarantee the smooth transition when cannula tip 514 being released from loading attachment and entering in sheath 542.

Can when not completing by means of when perspective cannula assembly 500 loaded so that under anchoring piece 518a, 518b are moved to folding configuration.Once cannula assembly 500 resides in sheath 542, perspective can be used for auxiliary cannula assembly 500 is delivered in every 30.Conical section 592 in loading attachment 578 can prevent from damaging (such as tearing) anchoring piece 518a, 518b when anchoring piece 518a, 518b are directed in loading attachment 578.When loading attachment 578 is retracted from the wheel hub 543 of delivery sheath 542 and when cannula assembly 500 (wherein anchoring piece 518 is in contraction state) is directed in delivery sheath 542 further, conical section 592 prevents from tearing anchoring piece 518a, 518b further.

Figure 23 A illustrates the Typical Disposition of circulatory assit system, comprises the cannula assembly 500 for the heart guide blood from patient.More specifically, the far-end 506 of casing main body 502 is communicated with right atrium 14 fluid of heart 15.Casing main body 502 from its laterally across every 30, upwards to be entered in subclavian vein 18 by superior vena cava 16.A position in subclavian vein 18, casing main body 502 is from wherein leaving and intake section 596 flow communication of the near-end 504 of casing main body 502 and pump 594.The outlet 598 of pump 594 is communicated with outflow sleeve pipe 600 fluid.Flow out sleeve pipe 600 to be communicated with subclavian artery 40, when flowing out sleeve pipe 600 and receiving blood from pump 594, blood is directed in subclavian artery 40 from outflow sleeve pipe 600.In the configuration shown in Figure 23 B, flow out top or rear that sleeve pipe 600 is arranged on subclavian vein.But, according to the anatomical structure of concrete patient, this outflow sleeve pipe 600 can be placed on subclavian vein 18 below or above.In the configuration, pump 594 is configured such that described intake section 596 is in the face of direction, inner side roughly or the center towards patient 20 health.Blood flows on the direction of arrow 42.

Figure 23 B illustrates the configuration of circulatory assit system, and it comprises boot adapter 602.Be similar to the configuration as shown in Figure 23 A, the far-end 506 of cannula assembly or main body 502 is communicated with right atrium 14 fluid of heart 15.Casing main body 502 from its laterally across every 30, upwards to be entered in subclavian vein 18 by superior vena cava 16.But a position in subclavian vein 18, casing main body 502 leaves, and the near-end 504 of casing main body 502 is connected to far-end or the distal part 604 of boot adapter 602, instead of directly connects adaptor with intake section 596.Then the far-end of boot adapter 602 or distal part 606 are connected with the intake section 596 of pump 594.In this configuration utilizing boot adapter 602, the intake section 596 of pump 594 towards substantial transverse direction, or usually towards the center away from patient 20 main body.The outlet 598 of pump 594 can be communicated with outflow sleeve pipe 600 fluid.Flow out sleeve pipe 600 to be then communicated with subclavian artery 40 fluid.Blood flows on the direction of arrow 42.More specifically, as shown in arrow 42, the blood flow in the far-end 604 of boot adapter 602 flows on substantial transverse direction relative to patient, and flows out the near-end 606 of boot adapter 602 and the blood entering intake section 596 flows on roughly direction, inner side relative to patient.

Boot adapter 602 is provided for multiple possible advantageous reasons.Boot adapter 602 reduces the pressure on subclavian vein 18.Boot adapter 602 is provided with the shape of curve substantially to reach the entrance 596 of pump 594, instead of make casing main body 502 bending arrive pump 594 entrance 596 thus to exert pressure adaptor from the position that it leaves to vein 18 at casing main body 502.

As more specifically illustrated in Figure 23 C-23D, boot adapter 602 also comprises far-end 604, near-end 606 and roughly shaped form main body 608 therebetween.The far-end 604 of boot adapter 602 connects with the near-end 504 of casing main body 502.For the ease of connecting, the far-end 604 of adaptor device 602 also comprises accessory 610, and it is suitable for the near-end 504 receiving described casing main body 502.In addition, swaged forging or crimp band 612 can be arranged on to provide other resistance in boot adapter 602, to prevent casing main body 502 from removing from the accessory 610 of boot adapter 602 is unwanted.The near-end 606 of adaptor device 602 connects with the entrance 574 of pump 594.In one embodiment, the near-end of boot adapter 602 and far-end 606,604 can use connector to be connected respectively to pump 594 and casing main body 502, and do not need extra securing member or stitching thread betwixt.Such as, the near-end 606 of boot adapter 602 buckle or ratcheting manner can be connected to pump intake 596.

Boot adapter 602 comprises roughly curved shape, and it adopts the configuration shown in Figure 23 B.In order to the flowing of favourable fluid, main body 608 is included in the conical section between near-end and far-end 606,604, and wherein said conical section is restricted to the reduced diameter portion being reduced to Second bobbin diameter 616 from the first diameter 614 between near-end and far-end 606,604 and divides.More specifically, due to the pyramidal structure of main body, thus inner chamber (not shown) is wherein configured to adaptor and prevents from occurring hole in pump 594 when pressure reduces along the length of boot adapter 602.In one embodiment, reduction is diametrically constant along conical section.

In addition, advantageously, the tapered configurations of boot adapter 602 allows in operation process, use relatively little casing main body 502 further, still utilizes existing and/or currently used pump 594 simultaneously.Therefore the size of the near-end 504 of casing main body 502 is preferably customized to and can be connected to blood pump known in the art, such as CircuLiteSYNERGY ^tMpump.Therefore, owing to can use the casing main body 502 of reduced size, therefore adaptor is for various operation process and patient widely, and boot adapter 602 can use in warp as herein described every apparatus and method.Such as use the casing main body 502 of reduced size to reduce to send its constraint by Venous system.

Although show the present invention by the description of various preferred embodiment, although these embodiments are described quite in detail, applicant is not intended to the restriction of the scope of claims or is restricted to such details by any way.Extra advantage and amendment will be easily manifested for those technical staff in this area.Depend on needs and the hobby of user, can be used alone or combinationally use various feature of the present invention with any.This is the explanation of the present invention together with such as known at present enforcement the preferred method of the present invention.But the present invention is only defined by the following claims itself.

Claims (16)

1. be suitable for the circulatory assit system that assist blood flows through patient circulatory system, described circulatory assit system comprises:

For the cannula assembly from patient's heart guide blood, described cannula assembly comprises flexible sleeve main body, and described flexible sleeve main body comprises near-end, far-end and inner chamber therebetween;

Pump, it enters in patient circulatory system for blood to be drawn in casing main body from heart and to be distributed from casing main body by blood, and described pump also includes an inlet and an outlet;

Be configured to be communicated with outlet and the outflow sleeve pipe of patient's tremulous pulse by fluid; And

Being configured to can the adaptor device of flow communication inlet and casing main body, and described adaptor device comprises portions of proximal, distal part and main body therebetween;

The distal part of wherein said adaptor device is configured to connect with the near-end of casing main body, and the portions of proximal of adaptor device is configured to connect with the entrance of described pump;

Wherein said adaptor device is roughly curved, the blood flow in adaptor device distal part is being flowed relative in the roughly lateral direction of patient, and makes to flow out adaptor device portions of proximal and enter into blood in entrance and flowing relative on the direction, roughly inner side of patient.

2. circulatory assit system according to claim 1, wherein said tremulous pulse is subclavian artery.

3. circulatory assit system according to claim 1, the inner chamber of wherein said adaptor device is included in the conical section between portions of proximal and distal part, and described conical section is restricted to the minimizing respectively from the first internal diameter to the internal diameter of the second internal diameter between portions of proximal and distal part.

4. circulatory assit system, comprising:

Cannula assembly, described cannula assembly also comprises:

Casing main body, it is for the heart guide blood from patient, and comprises near-end, far-end and inner chamber therebetween; And

The rigidity being connected to the entirety of casing main body far-end is most advanced and sophisticated, and the rigidity tip of described entirety has opening; And

Pump, it is for entering in patient circulatory system by distributing from cannula assembly in blood draw to cannula assembly and by blood;

Wherein the inner chamber of casing main body also comprises:

The first internal diameter in proximal end and the second internal diameter at far-end, described first internal diameter is greater than described second internal diameter; And

Conical section, its be restricted between the proximal and distal ends on internal diameter from the first internal diameter to the reduction of the second internal diameter, described conical section is configured to the cavitation preventing from occurring blood in sleeve pipe.

5. blood circulation according to claim 4, the described reduction wherein on internal diameter is between the proximal and distal ends constant.

6. circulatory assit system according to claim 4, the described reduction wherein on internal diameter only occurs along the part of inner chamber.

7. circulatory assit system, comprising:

There is the casing main body of near-end, far-end and inner chamber therebetween;

Pump, it is for entering in patient circulatory system by distributing from casing main body in blood draw to described casing main body and by blood; And

Most advanced and sophisticated in the rigidity of the entirety of the far-end of described casing main body, it is communicated with described cavity fluid and is configured to described inner chamber to be communicated with the chamber of heart, the rigidity tip of described entirety comprises distal part, described distal part has the first and second ends, described first and second ends have the first and second diameters respectively, described the second end is more farther than first end, and described Second bobbin diameter is greater than the first diameter, the rigidity tip of wherein said entirety is configured to prevent from entering integral rigidity tip and is advanced through the blood pressure reduction of sleeve pipe.

8. circulatory assit system according to claim 7, the distal part at the rigidity tip of wherein said entirety is restricted to roughly mitriform.

9. circulatory assit system according to claim 7, the Second bobbin diameter at wherein said integral rigidity tip is substantially equal to the external diameter of described cannula assembly far-end.

10. circulatory assit system, comprising:

There is the cannula assembly of near-end, far-end and inner chamber therebetween;

Pump, it is for entering in patient circulatory system by distributing from cannula assembly in blood draw to described cannula assembly and by blood; And

Delivery sheath, it is for being delivered through the blood circulation of patient by described cannula assembly, wherein said delivery sheath is configured to receive cannula assembly and moves relative to it so that contiguous cardiac chambers disposes cannula assembly, and comprises far-end, near-end and main body therebetween further;

The main body of wherein said delivery sheath also comprises the tensile elements of the longitudinal direction setting be embedded into wherein, and the described tensile elements longitudinally arranged is configured to prevent described bulk deformation when cannula assembly moves relative to delivery sheath.

11. circulatory assit systems according to claim 10, the wherein said tensile elements longitudinally arranged is configured to prevent the plastic deformation of delivery sheath substantially on axial direction.

12. circulatory assit systems according to claim 10, wherein said delivery sheath comprises the inwall and outer wall that are defined for the passage receiving cannula assembly further, and the described tensile elements longitudinally arranged is arranged between the inner and outer wall of delivery sheath.

13. circulatory assit systems according to claim 10, the wherein said tensile elements longitudinally arranged comprise following at least one: monofilament or multifilament.

14. circulatory assit systems according to claim 10, wherein, the described tensile elements longitudinally arranged comprise further following at least one: metal, fabric or polymer.

15. for the delivery system of delivery cannula molectron, and described cannula assembly comprises the anchoring piece anchoring to patient's heart, and described anchoring piece has contraction and extended mode, and described delivery system comprises:

Delivery sheath, described sheath is configured to receive cannula assembly and move relative to it so that under anchoring piece is deployed to extended mode; And

Loading attachment, it is configured to receive the anchoring piece that is under contraction state and assists delivery cannula molectron in delivery sheath, and wherein anchoring piece is in contraction state, and loading attachment also comprises:

Near-end, far-end and inner chamber therebetween, described near-end has the first internal diameter, and described far-end has the second internal diameter, and described first internal diameter is greater than the second internal diameter;

First internal diameter changes to the conical section of the second internal diameter in the lumen, and described conical section is configured to prevent from when delivery sheath receives cannula assembly damaging anchoring piece.

16. for being deployed to the method in patient circulatory system by circulatory assit Account Dept, described circulatory assit system comprises cannula assembly and pump, and described aid system is used for assist blood and flows through blood circulation, and described method comprises:

Cannula assembly be directed in the blood circulation of patient, the remote extension of wherein said cannula assembly is in the chamber of heart, and the near-end of described cannula assembly extends from described far-end in roughly lateral direction;

Implant the pump with entrance and exit, make described inlet face to the roughly lateral direction relative to patient;

Outflow sleeve pipe is used to be communicated with arterial fluid by delivery side of pump;

The distal part of the near-end of cannula assembly with adaptor device is connected; And

The portions of proximal of adaptor device is connected with the entrance of pump;

Wherein said adaptor device is roughly curved, makes to flow into blood in described adaptor device distal part relative to flowing in the roughly lateral direction of patient and flow out described adaptor device portions of proximal and the blood entered in entrance is flowing relative on the direction, roughly inner side of patient.